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Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers

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ClinicalTrials.gov Identifier: NCT01056094
Recruitment Status : Unknown
Verified April 2009 by Le MA, Health Science Center of Xi’an Jiaotong University.
Recruitment status was:  Recruiting
First Posted : January 26, 2010
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Health Science Center of Xi’an Jiaotong University
Information provided by (Responsible Party):
Le MA, Health Science Center of Xi’an Jiaotong University

Brief Summary:
Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing immune functions. A large number of epidemiological studies support the notion that a high intake of lutein is associated with a reduced risk of coronary heart disease and certain types of cancer. The biological mechanisms for the protective effects of this carotenoid, including powerful modulation of functions and antioxidant properties, are only partially known. Although several nutrients and phytochemicals have been shown to modulate immune functions in humans, few studies have investigated the role of lutein consumption. No information is available as to whether lutein supplementation could be protective against oxidative stress. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on oxidative stress in healthy subjects.

Condition or disease Intervention/treatment Phase
Oxidative Stress in Healthy Subjects Drug: Lutein Phase 1 Phase 2

Detailed Description:
Participants with a history of smoking, alcohol consumption, body mass index (BMI)≥30kg/m2, allergies, ocular diseases and participants taking vitamins or other food supplements containing lutein were excluded from the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Study Start Date : April 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Active Comparator: 20mg Lutein
Dietary Supplement: 20mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

Active Comparator: 10mg Lutein
Dietary Supplement: 10mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

Placebo Comparator: 0mg Lutein
Dietary Supplement: 0mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week




Primary Outcome Measures :
  1. Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult subjects aged in the range of 20 to 80

Exclusion Criteria:

  • Participants with a history of smoking
  • Alcohol consumption
  • Body mass index (BMI)≥30kg/m2
  • Allergies
  • Ocular diseases or recent infections(within the last year) and participants taking vitamins or other food supplements containing lutein the previous 2 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056094


Contacts
Contact: le ma, MD male@mail.xjtu.edu.cn

Locations
China, Shaanxi
Xi'an Jiaotong University College of Medicine Recruiting
Xian, Shaanxi, China, 710061
Contact: Le MA, MD       male@mail.xjtu.edu.cn   
Sponsors and Collaborators
Peking University
Health Science Center of Xi’an Jiaotong University

Responsible Party: Le MA, Xi'an Jiaotong University College of Medicine, Health Science Center of Xi’an Jiaotong University
ClinicalTrials.gov Identifier: NCT01056094     History of Changes
Other Study ID Numbers: CNS-06094
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: April 2009

Additional relevant MeSH terms:
Inflammation
Pathologic Processes